Boots Paracetamol & Codeine 500mg/8mg Tablets

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• This medicine can only be used for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
• You should only take this product for a maximum of 3 days at a time. If you need to take it longer than 3 days, you should consult your doctor or pharmacist for advice.
• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it.
• If you take this medicine for headaches for more than 3 days it can make them worse.

1. What Paracetamol & Codeine 500 mg/8 mg Tablets are and what they are used for
2. What you need to know before you take Paracetamol & Codeine 500 mg/8 mg Tablets
3. How to take Paracetamol & Codeine 500 mg/8 mg Tablets
4. Possible side effects
5. How to store Paracetamol & Codeine 500 mg/8 mg Tablets
6. Contents of the pack and other information

• Are under 18 years old and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome.
• Know you may metabolise very rapidly codeine into morphine.
• Are breastfeeding or planning to breast feed.
• Are allergic to Paracetamol, Codeine or any other similar painkillers such as dihydrocodeine, or to any of the other ingredients listed in section 6. Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue.
• Have liver disease or kidney failure.
• Have asthma or other breathing difficulties.
• Suffer from heart failure due to lung disease.
• Have recently suffered a head or brain injury.
• Are suffering from diarrhoea associated with colitis or due to any type of poisoning.
• Suffer from alcohol dependency.
• The person going to take the tablet is under 12 years old. Paracetamol & Codeine 500 mg/8 mg Tablets must not be given to children under 12 years old.
  Do not take Paracetamol & Codeine 500 mg/8 mg Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Paracetamol & Codeine 500 mg/8 mg Tablets.

Talk to your doctor, pharmacist or nurse before taking Paracetamol & Codeine 500 mg/8 mg Tablets if you:

• Experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine
• Have kidney or liver problems or alcoholic liver disease or a history of drug abuse.
• Suffer from high blood pressure or have an irregular heartbeat (slow or rapid).
• Have an underactive thyroid gland or adrenal gland.
• Have urinary or prostate problems.
• Have recently had surgery on your stomach, suffer from gallstones, bowel disorders or abdominal pain or swelling.
• Have ever suffered from convulsions or emotional problems.
• Are suffering from any kind of shock.
• Suffer from muscle weakness (myasthenia gravis).
• Have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Codeine is transformed to morphine in the liver by an enzyme.

Morphine is the substance that produces the effects of codeine and relieves pain and symptoms of cold. Some people have a variation of this enzyme that can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, which means it will not provide enough pain relief or relieve their cold. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Paracetamol & Codeine 500 mg/8 mg Tablets can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observes these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Paracetamol & Codeine 500 mg/8 mg Tablets can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Paracetamol & Codeine 500 mg/8 mg Tablets if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
  If you notice any of the following signs whilst taking Paracetamol & Codeine 500 mg/8 mg Tablets it could be a sign that you have become dependent or addicted:
• You need to take the medicine for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’.
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine.
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’).

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (see section 3, ‘If you stop taking Paracetamol & Codeine 500 mg/8 mg Tablets’).

Use in children and adolescents after surgery:

Paracetamol & Codeine 500 mg/8 mg Tablets should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children and adolescents with breathing problems:

Paracetamol & Codeine 500 mg/8 mg Tablets are not recommended in children with breathing problems, as the symptoms of morphine toxicity may be worse in these children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• Metoclopramide or Domperidone (for sickness and digestive disorders).
• Phenothiazines (to treat serious mental and emotional disorders).
• Colestyramine (to help control blood cholesterol levels).
• Cimetidine (to treat stomach ulcers).
• Cisapride (to treat heartburn).
• Quinidine or Mexiletine (to treat certain heart conditions).
• Naloxone or Naltrexone (to treat drug overdose or abuse).
• Chloramphenicol (to treat eye infections).
• Hydroxyzine (an antihistamine used to treat itching).
• Blood thinning medicines such as warfarin.
• Medicines to treat diarrhoea.
• Diuretics or other drugs for high blood pressure.
• Antimuscarinics (used to treat Parkinson's disease).
• Antidepressants including those known as monoamine oxidase inhibitors (MAOIs), anti-anxiety drugs, sedative or hypnotic drugs.
• Anaesthetics.
• Barbiturates (e.g., Phenobarbital).
• Any other paracetamol containing products.
• This medicine also contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Paracetamol & Codeine 500 mg/8 mg Tablets should not be taken by patients taking monoamine oxidase inhibitors (MAOI’s, e.g. moclobemide) or within two weeks of stopping treatment.

Paracetamol & Codeine 500 mg/8 mg Tablets may interfere with laboratory tests and you should inform your doctor if you have any tests scheduled.

Concurrent use of Paracetamol & Codeine 500 mg/8 mg Tablets with alcohol or barbiturates may increase the hepatotoxicity of paracetamol, particularly after overdosage.

Do not take Paracetamol & Codeine 500 mg/8 mg Tablets if you are pregnant or while breast-feeding. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Codeine and morphine pass into breast milk. Paracetamol & Codeine 500 mg/8 mg Tablets should not be used during breastfeeding (See the ‘Do not take Paracetamol & Codeine 500 mg/8 mg Tablets’ section).

Paracetamol & Codeine 500 mg/8 mg Tablets can affect your ability to drive as it can make you feel sleepy or dizzy. Do not drive whilst taking this medicine until you know how it affects you. It is an offence to drive if this medicine affects your ability to drive. However, you would not be committing an offence if:

• The medicine has been prescribed to treat a medical or dental problem and
• You have been following the instructions on how to take the medicine given by the prescriber and the medicine does not affect your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive whilst taking this medicine.

May cause allergic reactions (possibly delayed).

Talk to a doctor at once if you take too much of this medicine, even if you feel well because of the risk of delayed, serious liver damage. Take the container and any remaining tablets with you. Symptoms of overdose include loss of appetite (anorexia), nausea, diarrhoea, vomiting and abdominal pain.

Do not take a double dose to make up for the missed dose.

Taking Paracetamol & Codeine 500 mg/8 mg Tablets for a long time may lead to tolerance and dependence. Do not increase the dose or suddenly stop treatment without discussing this with your doctor.

If you experience any of these symptoms after taking this medicine go to the nearest hospital immediately:

• Allergic reactions which may be severe such as skin rashes and itching sometimes with swelling of the mouth or face or shortness of breath
• Skin rash or peeling, or mouth ulcers
• Fits (convulsions)
• Difficulty breathing. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin.
• Unexplained bruising or bleeding, throat and mouth ulcers or bleeding gums accompanied by tiredness and flu-like symptoms
• Inflammation of the liver (hepatitis).

• Nausea and vomiting
• Headache
• Hallucinations
• Sweating
• Flushing
• Loss of appetite
• Nightmares
• Dry mouth
• Vertigo
• Muscle twitches or stiffness
• Blurred or double vision
• Slow heart rate
• A fall in blood pressure on standing up (causing dizziness, light-headedness or fainting)
• Pounding heart
• Dizziness
• Depression
• Generally feeling unwell
• Problems in passing urine
• Stomach cramps
• Pancreatitis
• Tiredness
• Blood disorders which increases the risk of bleeding and bruising and makes infections more likely
• Codeine can affect your bowels and can cause incontinence, constipation, a watery diarrhoea like leakage, stomach pains and rarely, blockage of the bowel.

Very rare cases of serious skin reactions have been reported.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to this medicine.

However, if the following apply to you it is important that you talk to your doctor:

• You need to take the medicine for longer periods of time.
• You need to take more than the recommended dose.
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

The active substances are Paracetamol 500 mg and Codeine Phosphate 8 mg.

The other ingredients are pre-gelatinised maize starch, potato starch, povidone, talc, stearic acid, magnesium stearate, methyl p-hydroxybenzoate (E218), ethyl p-hydroxybenzoate (E214) and propyl p-hydroxybenzoate (E216).

They are white capsule shaped tablets, broken breakline and embossed with ac 500/8 on one side.

The other side is plain.

PL 08977/0012

Available in Pharmacy packs: 32 in blister strip.